Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
in Pharmaceutical Industries
Introduction:
Definition:
The need for improved product quality emerged in the 1980s, when it
became apparent that the United States was logging behind some
industrialized countries, most notably Japan, in the area of product quality.
Many of the tools and techniques that were used to identify quality
problems and take corrective action date back decades earlier. For
instance, Walter A. Shewhart, a Bell Labs statistician, developed a set of
methods in the 1920s that were designed to ensure standardization and
reduce quality defects. His book “Economic Control of Quality”, published
in 1931, is still considered a classic. Joseph M. Juran was a statistician who
in 1940s introduced the concept of “Pareto analysis”, which argues that 80
% of all quality problems may be traced to a relatively small number of
causes. Phillip Crosby spent his entire career at International Telephone
and Telegraph. While there, Crosby documented the enormous costs of
having to fix something that was not done right the first time. His ideas
were later published in the business best seller “Quality is Free”. Arnand V.
Feigenbaum developed the concept the concept of “total quality control” in
the 1940s, which argues for an integrated quality improvement effort
across all functional areas (e.g. purchasing, finance, marketing) and not only
in production and manufacturing. These ideas were later published in the
book, “Total Quality Control”.
Faysal Ahamed
Manarat International University
08. Employee empowerment
09. Flexible production
10. Process improvements
11. Process measuring
TQM model:
Customer
Focus
Total Planning
participation Process
TQM Model
Process Process
Improvement management
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Faysal Ahamed
Manarat International University
Fig: Total quality management (TQM)
Advantage of TQM:
01. Improves reputation- faults and problems are spotted and sorted
quicker.
02. Higher employee morale- workers motivated by extra responsibility,
team work and involvement indecisions of TQM
03. Lower cost – decrease waste as fewer defective products and no need
for separate.
04. Quality control inspector
Disadvantage:
Conclusion:
The professional, social and legal responsibilities that rest with the
pharmaceutical manufacturers for the assurance of product quality are
tremendous. It is only through well organized, adequately staffed accurately
performed process and dosage form control before, during and after production
that adequate quality assurance of the product can be achieved. It should be
realized that no amount of dosage form testing and control can maintain and
assure product quality unless good manufacturing practices (GMP) are
implemented systematically and process control is practiced rigorously. Product
quality must be building into and not merely tested in the product. The
pharmaceutical manufacturer assumes the major responsibility for the quality of
his products.
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Faysal Ahamed
Manarat International University
Reference:
1. Sudhanshu Bala Singh & Dr. R. S. Dhalla, “Effect of Total Quality
Management on Performance of Indian Pharmaceutical Industries”
Proceedings of the 2010 International Conference on Industrial Engineering
and Operations Management. Dhaka, Bangladesh, January 9 – 10, 2010.
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Faysal Ahamed
Manarat International University